China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that indication in China.
Orelabrutinib’s Expanding Indications and Reimbursement Status
Orelabrutinib, which was the third BTK inhibitor to gain approval in China, has previously been approved for use in r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL). The drug was added to the National Reimbursement Drug List (NRDL) in 2021, making it more accessible to patients in need.
International Expansion and Ongoing Studies
InnoCare has also secured approval for orelabrutinib in Singapore to treat recurrent/refractory MCL in December 2022. Furthermore, a global Phase II study for the drug’s use against multiple sclerosis (MS) is underway in the US. Phase II studies for systemic lupus erythematosus (SLE) and primary immune thrombocytopenia (ITP) in China have achieved proof of concept, with a study in neuromyelitis opticaspectrum disorders (NMOSD) well underway, indicating the drug’s potential in treating a range of autoimmune and neurological conditions.-Fineline Info & Tech
